Polycystic Liver DiseasePhase 2/3LOCKCYST-extNCT00771888
Open-Label Extension of LOCKCYST Trial
A Phase 2/3 study testing lanreotide in people with Polycystic Liver Disease and Hepatomegaly, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial summary
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases
- What is being tested?
- lanreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participated in the LOCKCYST trial
- 18 yrs-of age
- Multiple cysts > 20
- Cooperating patient
- Is willing and able to comply with the study drug regimen and all other study requirements.
- Willingness to give written informed consent
Who cannot join
- Use of oral anticonceptives or estrogen suppletion
- Females who are pregnant or breast-feeding
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Symptomatic gallstones (lanreotide decreases gall bladder volume)
- Renal failure requiring hemodialysis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, 6500 HB
About this study
Official title: Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.
Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.
Read the detailed description
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.
- Conditions
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
- Being tested
- lanreotide
- Medical subject headings
- Polycystic liver disease, Hepatomegaly, Liver Diseases, Polycystic Kidney Diseases, Multiple Pterygium Syndrome, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanreotideDrug
lanreotide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | lanreotide Receives: Drug: lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver volume reduction
Measured: 24 weeks
Secondary outcomes (1)
Kidney volume Cyst volume
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Investigators
- Joost PH Drenth, PhD, Principal investigator, Radboud University Nijmegen Medical CenterFrederik Nevens, MD, PhD, Principal investigator, University Hospital Gasthuisberg, University of LeuvenLoes van Keimpema, MSc, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771888
- Sponsor's protocol ID
- NL16194.091.07
- Acronym
- LOCKCYST-ext
- Status last verified
- Nov 2008
- First submitted
- 13 Oct 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut. 2008 Sep;57(9):1338-9. doi: 10.1136/gut.2008.155721. No abstract available.
PubMed 18719151
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers
- ClinicalTrials.gov ID
- NCT00771888
- Acronym / sponsor ID
- LOCKCYST-ext / NL16194.091.07
- Conditions
- Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Aug 2009 (estimated)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.
Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.
Detailed description
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: lanreotidelanreotide |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participated in the LOCKCYST trial
- 18 yrs-of age
- Multiple cysts > 20
- Cooperating patient
- Is willing and able to comply with the study drug regimen and all other study requirements.
Key exclusion criteria (7 listed)
- Use of oral anticonceptives or estrogen suppletion
- Females who are pregnant or breast-feeding
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotidelanreotide | Drug | 1 |
Primary outcome
Liver volume reduction
Time frame: 24 weeks
1 secondary outcome
Kidney volume Cyst volume
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
- Background: PubMed 18719151van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut. 2008 Sep;57(9):1338-9. doi: 10.1136/gut.2008.155721. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost PH Drenth, PhD principal investigator
Radboud University Nijmegen Medical Center
Frederik Nevens, MD, PhD principal investigator
University Hospital Gasthuisberg, University of Leuven
Loes van Keimpema, MSc principal investigator
Radboud University Nijmegen Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lanreotide in people with Polycystic Liver Disease and Hepatomegaly, run by Radboud University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver volume reduction (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2008.